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orlistat 9 articles

Xenical, Alli linked to neuropsychiatric side effects

The Food and Drug Administration (FDA) is reviewing cases of neuropsychiatric adverse events associated with use of Alli and Xenical capsules used for weight loss. Both Alli and Xenical contain the active ingredient orlistat. Alli is sold over-the-counter. Xenical is available by prescription only. The cases were identified in the quarterly (January-March 2017) Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS). The appearance of a drug on FAERS does not mean that the FDA has concluded that the drug causes the mentioned side effect. It means that the FDA has identified a ... Read More

Study: side effects of weight loss drug orlistat grossly underreported

Only a fraction of side effects associated with the obesity drug orlistat, sold as the prescription drug Xenical and the over-the-counter medicine Alli, were published in papers and summarized clinical study reports submitted to the European Medicines Agency (EMA), according to a study conducted by researchers with the Nordic Cochrane Centre in Copenhagen. The study used the Freedom of Information Act to acquire clinical study reports from the EMA that included seven randomized placebo-controlled trials of orlistat involving 4,225 patients. The data was reviewed by drug regulators in both the U.K. and the U.S., who voted to approve Xenical in ... Read More

Alli weight loss pills recalled due to potential tampering

GlaxoSmithKline (GSK) is recalling all of its Alli weight loss products in the United States and Puerto Rico after numerous reports across several states that packages may have been tampered with and may contain counterfeit pills. GSK received reports from customers in seven states that bottles of Alli tablets and capsules were not Alli. The counterfeit pills inside the bottles were in various shapes and colors. Some of the bottles inside the outer carton were missing labels and had tamper-evident seals that were not authentic. All of the tampered with products were purchased in retail stores. Alli is an over-the-counter ... Read More

FDA delays vote on experimental diet drug Qnexa

Approval for the experimental weight loss drug Qnexa has been pushed back another three months, paving the way for other drugs to stretch ahead in the race for the first diet pill in 13 years to be granted marketing rights in the United States. The Food and Drug Administration (FDA) pushed back the target date for approval to allow time to review a new safety plan submitted by drug maker Vivus Inc. These plans often include information that explains side effects and safety risks. Side effects reported with Qnexa include birth defects, heart palpitations, suicidal thoughts, and memory lapses. Vivus ... Read More

FDA advises diet drug makers to assess heart risks

Pharmaceutical companies who develop weight loss drugs need to study their medications to determine heart risks before seeking approval from health regulators, the Food and Drug Administration (FDA) said in a report released this week. Three drug companies are vying to get approval for what would be the first diet pills to hit the market in 13 years. Vivus’s drug Qnexa will be reviewed by an FDA panel in April, and Arena’s medication lorcasserin will be reviewed in May. Drug company Orexigen agreed in September to conduct safety studies on its diet pill, Contrave. Contrave hit a snag with FDA ... Read More

Popular weight-loss supplements pose injury and death risks, consumer group warns

The over-the-counter weight-loss drug Alli and its prescription form Xenical should be removed from the market immediately, warns Public Citizen, a national non-profit consumer advocacy group based in Washington D.C. The group has petitioned the Food and Drug Administration (FDA) for a ban of the popular drugs, citing evidence that they can cause severe, life-threatening injury to liver, pancreas, and kidneys. Alli and Xenical are forms of orlistat. Xenical contains 120 milligrams (mgs), while Alli, which is available without a prescription, contains half the amount of orlistat. Public Citizen says that the risks of serious injury far outweigh the drugs’ ... Read More

Experimental diet pill hopes to win FDA approval

Arena Pharmaceuticals and Eisai Co. have put their experimental diet pill back into clinical trials in hopes of gaining approval from the Food and Drug Administration (FDA). Qnexa, a combination of the weight loss drug phentermine and the antiepileptic medication topiramate (Topamax), was rejected by the FDA last fall because there was not enough data to measure the benefit/risk profile. The FDA also raised questions about early animal trials that showed the drug caused cancerous tumors in laboratory rats. The latest clinical trial involves nearly 2,500 overweight and obese men and women. Each were randomly assigned to diet and exercise ... Read More

New safety labels for Xenical, Alli warn of severe liver injury risk

Weight-loss drugs Xenical and Alli have added to their safety labels a new warning about an increased risk of severe liver injury, the Food and Drug Administration (FDA) reports. The warning follows an announcement late last summer of an investigation by the federal agency into 32 reports of serious liver injury and six cases of liver failure between 1999 and October 2008 in patients who took orlistat, marketed in the U.S. as the prescription Xenical and the over-the-counter Alli. The most recent evaluation by the FDA reviewed 13 reports of severe liver injury, 12 of which included foreign reports with ... Read More

Xenical, Alli reviewed by FDA after reports of serious liver injury

Reports of serious liver injury following the use of a popular weight loss drug, available by prescription and OTC, has prompted the Food and Drug Association (FDA) to investigate.  The drug in question, orlistat, is marketed in the U.S. as the prescription product Xenical and as the OTC product Alli. Both products are used for obesity management in conjunction with a reduced caloric diet and to reduce the risk of regaining weight after prior weight loss. Xenical was approved for use by prescription by the FDA in 1999. In 2007, Alli was approved for over-the-counter use. Currently, orlistat is approved ... Read More